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February 2020


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Kerri Orszula <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Thu, 6 Feb 2020 14:28:48 +0000
text/plain (45 lines)
I didn't see this one post so I am resending. Thank you!

From: Kerri Orszula
Sent: Wednesday, January 15, 2020 12:02 PM
To: [log in to unmask]
Subject: Annex 1- Gr B cont viable monitoring

Dear Forum,
      The Annex 1 draft has verbiage indicating continuous viable monitoring should be performed in Grade A and B for the full duration of critical processing. This seems to suggest that Grade B should be continuously monitored for viables.

How is this being interpreted? Is this something you will be implementing or will you be writing a risk assessment to justify why continuous viable monitoring in Grade B is not needed?

Thank you,

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